Obese Pregnant Women: Optimizing Fetal Ultrasound

• Conditions: Obesity; Fetal Malformation

• Registration Number: NCT02487641
• Lead Sponsor: Holbaek Sygehus

Brief Summary

This study aim to evaluate the quality of fetal ultrasound in obese pregnant women. The hypotheses is that an early ultrasound will improve the quality of the ultrasound in obese.

Detailed Description

Ultrasound examination for fetal anomaly is especially challenging in obese gravida. The foetus is more likely to have congenital anomalies and imaging in these patients is technically more difficult.

The investigators hypotheses that an earlier ultrasound with alternative technics will improve the quality and thereby improve the identification of anomalies. By using transvaginal ultrasound and abdominal ultrasound at the window just above the symphysis, were the subcutaneous fat is known to be thinner, the investigators hope to achieve a better overview. This will be done by evaluating fetal ultrasound at three different gestational ages (GA); GA 13, 15 and 21 weeks.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-09
• Last Update Posted: 2015-11-10
• Primary Completion: 2017-01
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Age ≥ 18
• BMI ≥ 30 Kg/m2
• BMI: 18,5-25 Kg/m2
• Understand and speak Danish and thereby be able to give confirmed consent.

Exclusion Criteria

• Multiple gestations
• Overweight (BMI: 25-29,9 Kg/m2)
• Alcohol or drug abuse
• Chronically diseases before pregnancy as diabetes, hypertension, or thyroid diseases
• Gastric bypass or other obesity related surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image quality of ultrasound at 15 compared with 21 weeks of gestation.	The participants will be examined for an hour at to different stages of the pregnancy (GA 14+0-15+0, GA 20+0-21+0)	Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.

Secondary Outcome Measures

Name	Time	Method
Image quality of ultrasound at 13 compared with 15 weeks of gestation.	The participants will be examined for an hour at to different stages of the pregnancy (GA 11+3 - 13+0, GA 14+0-15+0)	Image quality evaluated by experts on a visual analog scale from +50 - -50, parried with standardized ultrasound pictures at the above mentioned GA.
Analyses of BMI, visceral to subcutaneous fat ratio, distance from cutis to amnion and hip-waist ratio´s influence on image quality.	The participants will be examined for an hour at three different stages of the pregnancy (GA 13, GA 15, GA 21 and GA 36 weeks).
Weight estimate	The participants will be examined for an hour at GA 36 weeks. The participants will in all be followed until 6 months after birth, which is one year in all.	The use of weight estimate in obese pregnant women at GA 36 compared to birthweight.
Amnion fluid in obese	The participants will be examined for an hour at three different stages of the pregnancy (GA 15, GA 21, GA 36 weeks)	Measurement of amnion fluid by deepest vertical pocket and amnion fluid index.
Crown-rump length (CRL) measurement transvaginal and abdominal	The participants will be examined for an hour at GA 13 weeks.	Measurement of CRL in mm, by using two different probes, transvaginal and abdominal.

Trial Locations

Locations (1)

Department of Gynaechology and Obstetrics, Holbaek Hospital; 🇩🇰 Holbaek, Denmark